A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma
NCT ID: NCT01632228
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2012-06-29
2016-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Onartuzumab + Bevacizumab
All participants will receive onartuzumab intravenous (IV) infusion followed by bevacizumab IV infusion every 3 weeks.
Bevacizumab
Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Onartuzumab
Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Placebo + Bevacizumab
All participants will receive placebo matched with onartuzumab followed by bevacizumab IV infusion every 3 weeks.
Bevacizumab
Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Placebo
Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Interventions
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Bevacizumab
Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Onartuzumab
Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Placebo
Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Imaging confirmation of first tumor progression or regrowth as defined by RANO criteria
* Prior treatment with temozolomide
* No more than one prior line of chemotherapy
* No prior treatment with bevacizumab or other vascular endothelial growth factor (VEGF)- or VEGF-receptor-targeted agent
* No prior exposure to experimental treatment targeting either hepatocyte growth factor (HGF) or Met pathway
* No prior treatment with prolifeprospan 20 with carmustine wafer
* No prior intracerebral agent
* Recovery from the toxic effects of prior therapy
* No evidence of recent hemorrhage on baseline magnetic resonance imaging (MRI) of the brain
* No need for urgent palliative intervention for primary disease (e.g. impending herniation)
* Karnofsky performance status greater than or equal to (\>=) 70 percent (%)
* Stable or decreasing dose of corticosteroids within 5 days prior to randomization
* Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the participant must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
* Participants who have undergone recent surgery for recurrent or progressive tumor are eligible provided that: surgery must have confirmed the recurrence, a minimum of 28 days must have elapsed from the day of surgery to randomization and for core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization, and craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization
* Availability of formalin fixed paraffin embedded tumor tissue representative of glioblastoma
Exclusion Criteria
* Inadequate hematologic, renal or liver function
* History or presence of serious cardio-vascular disease
* New York Heart Association Grade II or greater congestive heart failure
* History of another malignancy in the previous 3 years, except for in situ cancer or basal or squamous cell skin cancer
* Inadequately controlled hypertension (defined as systolic blood pressure greater than \[\>\]150 millimeter of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while on antihypertensive medication)
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
* Known hypersensitivity to any excipients of onartuzumab or bevacizumab
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama At Birmingham; Neuro-Oncology
Birmingham, Alabama, United States
Cedars Sinai Medical Center; Neurosurgery
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
USCF - Neurosurgery
San Francisco, California, United States
Stanford Comprehensive Cancer Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Florida Cancer Specialists - Englewood
Englewood, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
North Western Univ; Neurology
Chicago, Illinois, United States
Northshore University Health System; Cardiology
Evanston, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Hatton Research Institutes
Cincinnati, Ohio, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States
Baylor Research Inst.
Dallas, Texas, United States
University of Virgina
Charlottesville, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Seattle Cancer Care Alliance; Investigational Drug Service
Seattle, Washington, United States
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727
Toronto, Ontario, Canada
McGill University; Montreal Neurological Institute; Oncology
Montreal, Quebec, Canada
CHUS Hopital Fleurimont; CRC
Sherbrooke, Quebec, Canada
Hopital Avicenne; Neurologie
Bobigny, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, , France
Hopital Roger Salengro
Lille, , France
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
Marseille, , France
Centre Val Aurelle Paul Lamarque; Medecine B3
Montpellier, , France
Hôpital Central; Departement de Neuro-Oncologie
Nancy, , France
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Paris, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Hopital Purpan
Toulouse, , France
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
Bonn, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt am Main, , Germany
Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie
Hamburg, , Germany
Ärztehaus Velen
Ibbenbühren, , Germany
Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie
Mainz, , Germany
Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie
München, , Germany
Pius-Hospital
Oldenburg, , Germany
Ospedale Bellaria; U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy
Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia
Cesena, Emilia-Romagna, Italy
A.O. Universitaria Di Parma; Oncologia Medica
Parma, Emilia-Romagna, Italy
Spedali Civili di Brescia
Brescia, Lombardy, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milan, Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia
Pisa, Tuscany, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, Spain
Hospital Clinic i Provincial; Servicio de Farmacia
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, , Spain
HUG; Oncologie
Geneva, , Switzerland
Universitätsspital Zürich; Klinik für Neurologie
Zurich, , Switzerland
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Nottingham City Hospital; David Evans Centre
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2011-005912-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27819
Identifier Type: -
Identifier Source: org_study_id
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